Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS, and C-reactive protein (CRP) (mg/dL). SDAI is defined as follows: ≤3.3, disease remission; \>3.3 to ≤11, low disease activity, \>11 to ≤26, moderate disease activity; and \>26, high disease activity. SDAI was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI.

Time frame: Baseline, 1, 6, 12, 24, 36 months

Population: The MTX adherent efficacy analysis set (n=4455) comprised of participants who received XELJANZ Tablets 5 mg at least once for the treatment of poorly controlled RA despite continuous use of MTX, excluding participants who were confirmed ineligible or not assessable for effectiveness. Of the 4455 MTX adherent efficacy analysis set, the participants with available results at each evaluation point are described.

DAS28 is the numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, PtGA assessed on 0-10 cm VAS, and the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]). DAS28 is defined as follows: \<2.6, disease remission; ≥2.6 to \<3.2, low disease activity, ≥3.2 to ≤5.1, moderate disease activity; and \>5.1, high disease activity. DAS28 was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI.

Time frame: Baseline, 1, 6, 12, 24, 36 months

Population: The MTX adherent efficacy analysis set (n=4455) comprised of participants who received XELJANZ Tablets 5 mg at least once for the treatment of poorly controlled RA despite continuous use of MTX, excluding participants who were confirmed ineligible or not assessable for effectiveness. Of the 4455 MTX adherent efficacy analysis set, the participants with available results at each evaluation point are described.

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious adverse event/adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XELJANZ was assessed by the physician.

Time frame: 36 months

Population: The MTX adherent safety analysis set (n=4574) comprised of participants who received XELJANZ Tablets 5 mg at least once for the treatment of poorly controlled RA despite continuous use of MTX, excluding participants who did not meet the conditions to receive MTX, participated in a clinical trial, or transferred to another hospital.

Comparison of time to death between XELJANZ group and control group. The standardized mortality ratio (SMR) was calculated using the general Japanese population as the reference population. Hazard ratio (unadjusted): Baseline characteristics are unadjusted

Time frame: 36 months

Population: The MTX adherent comparative safety analysis set comprised of participants who satisfied the inclusion criteria and had received XELJANZ Tablets 5 mg or other treatment at least once for the treatment of poorly controlled RA despite continuous use of MTX.

Comparison of time to malignancy between XELJANZ group and control group. The standard incidence ratio (SIR) was calculated using the general Japanese population as the reference population. Hazard ratio (unadjusted): Baseline characteristics are unadjusted Hazard ratio (adjusted 1): Adjusted by propensity score estimated by logistic regression Hazard ratio (adjusted 2): Adjusted by propensity score estimated by random forest Hazard ratio (adjusted 3): Adjusted by propensity score estimated by logistic regression (with upper limit of weighting) Hazard ratio (adjusted 4): Adjusted by propensity score estimated by random forest (with upper limit of weighting)

Time frame: 36 months

Population: The MTX adherent comparative safety analysis set comprised of participants who satisfied the inclusion criteria and had received XELJANZ Tablets 5 mg or other treatment at least once for the treatment of poorly controlled RA despite continuous use of MTX.

Comparison of time to serious infection between XELJANZ group and control group. Hazard ratio (unadjusted): Baseline characteristics are unadjusted Hazard ratio (adjusted 1): Adjusted by propensity score estimated by logistic regression Hazard ratio (adjusted 2): Adjusted by propensity score estimated by random forest Hazard ratio (adjusted 3): Adjusted by propensity score estimated by logistic regression (with upper limit of weighting) Hazard ratio (adjusted 4): Adjusted by propensity score estimated by random forest (with upper limit of weighting)

Time frame: 12 months

Population: The MTX adherent comparative safety analysis set comprised of participants who satisfied the inclusion criteria and had received XELJANZ Tablets 5 mg or other treatment at least once for the treatment of poorly controlled RA despite continuous use of MTX.